Study on Capivasertib and Paclitaxel as First Treatment for Advanced or Metastatic Triple-Negative Breast Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT03997123
This clinical trial is testing a combination of the drugs Capivasertib and Paclitaxel to see if they are effective as the first treatment for patients with advanced or metastatic triple-negative breast cancer (TNBC).
Patient Parameters
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Program Overview
The purpose of this study is to compare the effectiveness and safety of the drug combination Capivasertib and Paclitaxel against a placebo and Paclitaxel in patients with advanced or metastatic triple-negative breast cancer (TNBC). This is a Phase III trial, which means it is in the later stages of testing to determine how well the treatment works and how safe it is for patients.
Description
This study is a Phase III trial, which means it is in the later stages of testing to determine how well the treatment works and how safe it is for patients. The trial is double-blind and randomized, meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo, to ensure unbiased results. The study focuses on patients with triple-negative breast cancer that is either locally advanced and cannot be surgically removed or has spread to other parts of the body. Participants will receive either the combination of Capivasertib and Paclitaxel or a placebo with Paclitaxel to see which is more effective as a first-line treatment.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of triple-negative breast cancer from the most recent tumor sample.
- Have cancer that is either metastatic (spread to other parts of the body) or locally advanced and cannot be surgically removed.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have measurable disease according to standard criteria, or bone lesions that can be assessed by scans.
- Provide a tumor sample from primary or recurrent cancer.
Exclusion Criteria
- Have received chemotherapy in the past 6 months for early-stage cancer, or taxane chemotherapy in the past 12 months.
- Have had previous treatment for inoperable or metastatic cancer.
- Have taken certain medications, including AKT, PI3K, or mTOR inhibitors, or Capivasertib in this study.
- Have used other cancer treatments or medications affecting liver enzymes within a specified time before the study.
- Have had recent wide-field radiation therapy.
- Have significant nerve damage or unresolved side effects from previous treatments.
- Have certain heart conditions or risk factors for heart problems.
- Have uncontrolled blood sugar levels or diabetes requiring insulin.
- Have inadequate bone marrow or organ function.
- Be pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 90602 | Whittier | California |
| Research Site | 90603 | Whittier | California |
| Research Site | 33901 | Fort Myers | Florida |
| Research Site | 33136 | Miami | Florida |
| Research Site | 33705 | St. Petersburg | Florida |
| Research Site | 33612 | Tampa | Florida |
| Research Site | 60637 | Chicago | Illinois |
| Research Site | 66205 | Westwood | Kansas |
| Research Site | 20910 | Silver Spring | Maryland |
| Research Site | 48202 | Detroit | Michigan |
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